Laboratory Operations Specialist

About the role

This role will oversee and support daily laboratory operations in a pharmaceutical manufacturing environment. Candidates need to have a strong background in laboratory systems, equipment qualification, and compliance with GxP and GMP regulations. The ideal candidate will have hands-on experience with laboratory processes, instrumentation, and regulatory requirements specific to the pharmaceutical industry. As a Laboratory Operations Specialist, you will ensure the smooth operation of laboratory systems, perform equipment qualification and maintenance, and support the implementation of laboratory improvements that enhance compliance and efficiency.

Responsibilities

• Laboratory Operations Management:
• Oversee the day-to-day operations of the laboratory to ensure compliance, efficiency, and reliability.
• Collaborate with laboratory staff to maintain smooth workflows and resolve operational challenges.
• Provide technical support and troubleshooting assistance for IT systems, including hardware, software, and network infrastructure.
• Equipment Qualification and Maintenance:
• Perform and document laboratory equipment qualification (IQ, OQ, PQ) in compliance with GxP and GMP standards.
• Schedule and conduct routine calibration, maintenance, and repairs for laboratory instruments and equipment.
• Troubleshoot equipment issues and coordinate with vendors for advanced technical support as needed.
• Compliance and Documentation:
• Ensure laboratory operations and equipment are compliant with regulatory standards, including GxP, GMP, and other pharmaceutical guidelines.
• Maintain accurate and up-to-date documentation for all equipment qualifications, maintenance, and operational activities.
• Support audits and inspections by preparing required documentation and addressing compliance queries.
• Process Improvement:
• Identify and implement improvements to laboratory operations, workflows, and systems.
• Assist in the integration of new laboratory technologies and methodologies to enhance efficiency and compliance.
• Training and Support:
• Train laboratory staff on equipment usage, qualification procedures, and operational best practices.
• Provide technical support and guidance to ensure laboratory operations meet high standards of quality and compliance.
• Regulatory Support:
• Collaborate with quality assurance teams to align laboratory operations with regulatory requirements.
• Participate in the development and review of Standard Operating Procedures (SOPs) related to laboratory activities.

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or a related field.
• Proven experience in laboratory operations within the pharmaceutical manufacturing industry.
• Hands-on experience with laboratory equipment qualification (IQ, OQ, PQ) and maintenance.
• Strong understanding of GxP, GMP, and other pharmaceutical regulatory requirements.
• Proficiency in laboratory instruments and systems, including troubleshooting and maintenance.
• Excellent organizational and documentation skills, with strong attention to detail.
• Ability to manage multiple priorities in a dynamic, fast-paced environment.
• Strong interpersonal and communication skills to collaborate effectively with laboratory staff, vendors, and regulatory bodies.
• Contract Period: 12 months, subject to renewal based on performance.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at NUSANTARA PRIME CONSULTING PTE. LTD.? Share your experience